New E-Service for a Dietary Approach to the Elderly

Healthy Clinical Trial

— RISTOMED  

Official title:

Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. German Part of a Multicentric European Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179789
• Other study ID #: EA1/079/09
• Status: Completed
• Phase: Phase 0
• First received: August 5, 2010
• Last updated: October 27, 2011
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Ageing of the population is a major event in the world. Gerontological/geriatric literature unanimously indicate that physical exercise and diet are at present the two available fundamental approaches to contrast/prevent most of the age associated alterations. In the elderly the inflammageing, the oxidative stress and the alteration of the intestinal microbiota can be influenced by nutritional status and possibly corrected by an appropriate dietetic intervention:

Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs

Description:

Ageing of the population is a major event in the world. Gerontological/geriatric literature unanimously indicate that physical exercise and diet are at present the two available fundamental approaches to contrast/prevent most of the age associated alterations. In the elderly the inflammageing, the oxidative stress and the alteration of the intestinal microbiota can be influenced by nutritional status and possibly corrected by an appropriate dietetic intervention:

Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age: from 65 to 85 years

• Body Mass Index: 22-30 kg/m2

• ECOG Performance status: WHO performance score 0 to 2

• Absence of known diseases and/or abnormalities of haematological parameters (haematological, inflammatory, metabolic, hepatic and renal diseases)

• The subjects must be able to comply with management of nutraceutical products and with scheduled follow-up

• The subjects must be able to use the computer and to access to the web, by themselves or with the help of a caregiver

Exclusion Criteria:

• History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder

• Geriatric anorexia [less than 2 full meals per day and /or less than one serving of dairy products (milk, cheese, yogurt) per day or two or more servings of legumes or eggs per week or one serving of meat, fish or poultry every day]

• Weight loss > 5% in the last month

• Previous antibiotic treatment within 4 months

• Active infection requiring per OS or IV antibiotics, including active tuberculosis, known and declared HIV, HCV

• Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy

• Gastric disease that requires medical therapy (e.g. gastric secretion inhibitory drugs)

• Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis, diverticulosis, diverticulitis)

• Diabetes mellitus

• Dislipidemia and/or any metabolic disease that requires medical or dietetic treatment

• Myocardial infarction within 6 months prior to study entry, congestive heart disease, uncontrolled cardiac insufficiency, and any current grade 3 or 4 cardio-vascular disorder despite treatment

• Current history of neoplasm except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix and except for other cancer curatively treated and with no evidence of disease for at least 5 years

• Other sever underlying medical conditions, which could impair the ability of the patient to participate in the study

• Chronic anti-inflammatory therapy with FANS or previous therapy within 20 days from the beginning of the study. The occasional use of anti-inflammatory therapy is not an exclusion criteria, but the use is not allowed within 3 days before the analysis and for more than 8 days/2 months during the study

• Previous (within 15 days) or concomitant treatment that modifies intestinal absorption (e.g. metformin, acarbose in diabetic treatment…)

• Probiotics, prebiotics or symbiotics (yogurt or another functional foods) intake in the last 3 weeks

• Use of food supplements or functional foods such as probiotics, prebiotics, symbiotics, vitamins and minerals different than whose established in this study, is not allowed during the study period or previously within 1 week (except for vitamin D, calcium, vitamin B12)

• Total parenteral nutrition within 4 months

• History of allergy to one of the excipients present in the products under evaluation

• Concomitant or within 4 week period administration of any experimental drug, food supplements or nutraceuticals under investigation

• Subjects clearly intending to withdraw from the study if not randomised in a given arm, or subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons

• Subjects with expected non-compliance to protocol guidelines

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aged
• Healthy

Intervention

Behavioral:
• Optimal Diet
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform

Dietary Supplement:
• VSL#3®
probiotic blend Product should be administrated orally, 2 capsules b.i.d. on an empty stomach (at least 30 min. before lunch and dinner) with a glass of water
• AISA-5203-L
fruit extracted terpene Product should be administrated orally, the dosage depending from the body weight of the subject enrolled in the study as already stated : 1-2 pills three times a day with a meal and a large glass of water
• Argan oil
Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Devaraj S, O'Keefe G, Jialal I. Defining the proinflammatory phenotype using high sensitive C-reactive protein levels as the biomarker. J Clin Endocrinol Metab. 2005 Aug;90(8):4549-54. Epub 2005 May 17. — View Citation

Franceschi C, Valensin S, Bonafè M, Paolisso G, Yashin AI, Monti D, De Benedictis G. The network and the remodeling theories of aging: historical background and new perspectives. Exp Gerontol. 2000 Sep;35(6-7):879-96. Review. — View Citation

Mendall MA, Patel P, Ballam L, Strachan D, Northfield TC. C reactive protein and its relation to cardiovascular risk factors: a population based cross sectional study. BMJ. 1996 Apr 27;312(7038):1061-5. — View Citation

Wener MH, Daum PR, McQuillan GM. The influence of age, sex, and race on the upper reference limit of serum C-reactive protein concentration. J Rheumatol. 2000 Oct;27(10):2351-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk)		2 months	No
Secondary	Inflammageing status as measure of ageing-associated inflammatory processes	WBC, hemoglobin, erythrocyte sedimentation rate, fibrinogen, total cholesterol, triglycerides, insulin, glucose, IL-6, TNFa, IL-10, TGF-1, IGF-1, adiponectin, leptin, homocysteine, folic acid and vitamin B12	2 months	No
Secondary	Oxidative stress	Plasma total antioxidant capacity by TEAA (Trolox Equivalent Antioxidant Activity), glutathione , superoxide dismutase, glutathione peroxidase, glutathione reductase, catalase activities	2 months	No
Secondary	Gut micobiota	Expression of 16S ribosomal RNA bacterial groups from feces by RT-PCR. Ratio between lactobacilli and clostridia bacteria as measure of impact of personalized nutrition with and without nutraceuticals on gut microbiota.	2 months	No
Secondary	Quality of life (QoL)	Daily visual analogue scale, SF-36 and General Health Questionnaire (GHQ) as direct measures of QoL. ECOG performance status, IADL, Spielberger Anxiety Index (SAI), and CED-D scale as indirect measures of quality of life.	2 months	No
Secondary	Physical performance status	Short physical performance battery (SBBP), muscle function (hand-grip dynamometry, and physical activity level (IPAQ).	2 months	No
Secondary	Compliance	Daily visual analogue scales as measures of compliance to web diet advices and to the nutraceutical intake.	2 months	No